Counterfeit Drug Count Is Tough to Swallow

By

Carl Bialik

Updated Sept. 11, 2010 12:01 a.m. ET

A television commercial is breathing new life into a dubious, old statistic about counterfeit drugs.

"I have a drug problem," Paul Chang, IBMIBM0.64% business strategist for emerging technologies, says in the ad. "Ten percent of the world's medicine is counterfeit." The ad touts IBM technology to tag drug packaging to screen for fakes, which can be merely impotent or downright toxic.

But the statistic itself might be fake. It long has been attributed to the World Health Organization or the U.S. Food and Drug Administration, but both agencies today disavow it. Fake pills likely make up 1% of sales or less in developed countries, where most drugs are sold, according to WHO.

"Ten percent is a nice, round number that many in the industry are touting as the size of the problem," says Mr. Chang, in an interview. "Of course, it's an estimate. No one knows what that number is." He says he cites the figure in talks with government agencies and prospective customers for IBM's anti-counterfeiting tools. It also is repeated frequently in news articles, statements by drug companies and, earlier this year, by former French President Jacques Chirac, speaking at a meeting of the World Customs Organization.

Numbers Guy Blog

This supposed fact about the global drug market appears to be a familiar sort of questionable statistic: one that has been repeated so often, no one is sure where it originated.

Fake drugs are designed to look like real pills, and the best can fool a room of experts. Some contain harmless ingredients but no active ones; others are toxic and dangerous; and some even mimic the properties of their legal counterparts, but are counterfeit because they aren't made by the patent owner for that drug.

Peter Pitts, president of the pharmaceutical industry-backed Center for Medicine in the Public Interest, says that while there hasn't been a reliable study tracking the extent of counterfeits, fake drug sales are a growing problem.

The 10% figure appears to have surfaced initially in a 2002 editorial in the British Medical Journal, which reported that "the World Health Organization estimates that 10% of global pharmaceutical commerce is in fakes." The article attributed the WHO estimate to a study published in 1999 on counterfeit drugs in Myanmar and Vietnam. For the study, WHO researchers tested samples of 500 drugs, specifically selected because they were considered particularly susceptible to counterfeiting. A little over one in 10 didn't contain the labeled amount of active ingredient. But the paper made no claim about the overall counterfeiting rate in those countries, let alone world-wide.

"I am uncertain, after eight years, why there is the mismatch between the reference and the percentage," Paul Newton, co-author of the BMJ editorial, wrote in an email. "I do not trust any global poor-medicine-quality percentages," says Dr. Newton, a senior scientist in tropical medicine at the University of Oxford in England. "However, even 1% of essential medicines being poor-quality is a severe public-health problem."

His 2002 editorial was picked up by several major news organizations, and soon 10% became a commonly accepted figure, attributed to WHO. The health agency itself included the estimate in several statements and fact sheets. The FDA, meanwhile, cited the 10% figure in a 2004 report, attributing it to WHO. Spokeswomen for both organizations say the origin of the figure is unclear.

The WHO attempted to shed light on the issue in a 2006 paper that began, "For the past few years the public opinion and expert circles have passively accepted the argument that 10% of medicines around the world could be counterfeit. This number however, is not supportable."

More Numbers Guy

The WHO paper pointed out the wide variation in fake-drug rates, from less than 1% in developed countries, according to the WHO, to between 10% and 30% in developing countries and former Soviet republics. Since about three-fourths of drug sales are in the developed world, that translates into a global counterfeiting estimate closer to 5% than 10%.

Lembit Rago, WHO coordinator for quality and safety of medicines, says that 10% is "probably a bit exaggerated," emphasizing that he is expressing his personal opinion, not that of WHO.

Adding to the confusion is that some mentions of counterfeiting imply that the 10% figure refers to units of medicine, rather than the more common revenue barometer.

Dr. Rago says that while he believes the total share of fake drugs world-wide is closer to 5%, pinpointing the figure would be very difficult. "There is not a single scientifically solid methodology able to do that," he says. "But I think we know, from expert opinions and what has been verified, enough to conclude it is still a serious problem."

This copy is for your personal, non-commercial use only. Distribution and use of this material are governed by our Subscriber Agreement and by copyright law. For non-personal use or to order multiple copies, please contact Dow Jones Reprints at 1-800-843-0008 or visit www.djreprints.com.